MAUDE Adverse Event Report: MPRI ATTAIN OVER THE WIRE LEAD; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	419388
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cardiac resynchronization therapy defibrillator (crt-d) replacement procedure the patient experienced asystole.It was noted that the right ventricular (rv) lead did not capture when it was placed back into the header of the crt-d.When the rv lead was removed from the header the left ventricular (lv) lead also exhibited loss of capture due to the programming configuration, the lv lead was programmed lv to rv tip.It was suspected that the rv lead pin may not have been inserted all the way back in the header when the loss of capture remained.The crt-d replaced was completed and the leads remain in use. no further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: dtma1d4 crt-d, implant date: (b)(6) 2019; 6935m62 lead, implant date: (b)(6) 2019.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a cardiac resynchronization therapy defibrillator (crt-d) replacement procedure the patient experienced asystole.It was noted that the right ventricular (rv) lead did not capture when it was placed back into the header of the crt-d.When the rv lead was removed from the header the left ventricular (lv) lead also exhibited loss of capture due to the programming configuration, the lv lead was programmed lv to rv tip.It was suspected that the rv lead pin may not have been inserted all the way back in the header when the loss of capture remained.The crt-d replaced was completed and the leads remain in use.No further patient complications have been reported as a result of this event.It was further reported that the lead connector pins were reinserted into the new device header during the procedure and normal lead measurements and device behavior were observed.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ATTAIN OVER THE WIRE LEAD
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 20429244
• Report Number: 2649622-2024-27174
• Device Sequence Number: 7627344
• Product Code: LWP
• UDI-Device Identifier: 00885074200736
• UDI-Public: 00885074200736
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/05/2008
• Device Model Number: 419388
• Device Catalogue Number: 419388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 10/31/2024
• Date Device Manufactured: 01/09/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 407652 LEAD.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male